Investigating the effects of Empagliflozin on heart function after unexplained strokes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the impact of Empagliflozin, a Sodium Glucose Cotransporter 2 (SGLT2) inhibitor, on left atrial function in patients who have experienced an embolic stroke of undetermined source. The study will involve patients who have been referred for an implantable loop recorder to monitor potential atrial dysrhythmias. By assessing changes in atrial strain, the trial seeks to determine if Empagliflozin can prevent the development of atrial fibrillation, thereby reducing the risk of future strokes. The study is designed as a randomized control trial and will include both Phase 2 and Phase 3 evaluations.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age over 18 years
* Patient has had an embolic stroke of undetermined source, defined as:

  * Ischaemic stroke or transient ischaemic attack diagnosed clinically + supporting radiological features on CT or MRI imaging
  * No clinically significant extracranial or intracranial atherosclerosis found on neck imaging
  * No evidence of prevalent cardioembolic source of embolism - atrial dysrhythmia, cardiac thrombus, prosthetic valve, cardiac tumours, mitral stenosis, recent MI, LVEF\<35%, valvular vegetations, or infective endocarditis

AND

* No other specific stroke aetiology identified (pro-thrombotic states, arteritis, dissection, drug abuse)
* Patient has been referred for an implantable loop recorder implant to investigate possible atrial dysrhythmia
* Ability to give written, informed consent

Exclusion Criteria:

* Prevalent atrial fibrillation or atrial flutter
* Subsequent demonstration of a cardio-emoblic source
* Pre-existent indication for SGLT2i including heart failure with a reduced ejection fraction and Type 1 or Type 2 diabetes mellitus
* Contraindication to the commencement of SGLT2i including a history of, or risk factors for diabetic ketoacidosis, such as restricted food intake or a history of alcohol abuse
* Hypersensitivity to the active substance or to any of the excipients of empagliflozin
* Presence of alternate implantable cardiac devices such as a pacemaker or defibrillator, that would make ILR utilisation redundant
* Any condition that may confound the results or interfere with participation such as dementia
* An unwillingness to participate

Where it's running

• Addenbrookes Hospital
  Cambridge, Cambridgeshire, United Kingdom Recruiting

Study contacts

• Study coordinator: Vassilios S Vassiliou, PhD
• Email: V.Vassiliou@uea.ac.uk
• Phone: 01603592534

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.